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Genetics Institute/Wyeth Work Values
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Daily Duties at Genetics Institute/Wyeth:
Regulatory Project Leader for an investigational immunosuppressive biologic with clinical indications in solid organ and bone marrow transplantation. The product consisted of 2 novel monoclonal antibodies used in combination. Coordinated all pre-IND activities, submitted 2 US IND applications and managed resolution of regulatory issues pertaining to clinical trial design and the combined use of two novel agents untested in humans, and manufacturing changes. Participated on cross-functional project teams providing regulatory guidance on pre-clinical and clinical development strategies, including Orphan Drug, Fast Track and Accelerated Approval. Regulatory Project Leader for a recombinant fusion protein being developed for acute coronary syndromes. Responsible for all product-related regulatory interactions and activities including informational and face-to-face pre-IND meetings with the FDA and Canadian Health Authorities, clinical trial application submissions (1 US IND and 1 Canadian CTA), and resolution of clinical and CMC regulatory issues. Provided strategic regulatory guidance to cross-functional project teams. Managed regulatory project team and coordinated all international regulatory activities including filing of clinical trial applications in France, Germany, Belgium and Spain. Coordinated Latin American filings with CRO.
What they like about Genetics Institute/Wyeth:
Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.
Skills
Information about Genetics Institute/Wyeth
Company Rank: Not Available
Average length of employment : 2 years
Average salary of employees: $127,500
These are some of the questions we asked our climbers about their experiences with Genetics Institute/Wyeth:
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| I believe in the purpose of this organization. | 0.0 | |
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| I feel employees are fairly compensated. | 0.0 |
